Review of PDI 2013 Parenteral Drug Industry Congress 2013 (PDI 2013) was held on Jun. 19-21, 2013 in International Nanjing Hotel. Information of PDI 2013 Organizer: Organizing Committee of PDI 2013 Supporters: Parenteral Drug Association Center For Certification & Evaluation, JSFDA China Pharmaceutical Association of Plant Engineering China Pharmaceutical Packaging Association China Pharmaceutical Enterprises Association Agenda of PDI 2013 Structure of PDI 2013 Date Time Forum June 19 8:00-12:00 Parenteral Drug Manufacturer Executive Venue Summit （Separate registration is needed. Registration fee is 1500 RMB. Attendees have access to Regulation Forum in the afternoon） Nanjing Celebrity City Hotel, Nanjing Meeting Room Theme：Status and Future of IV Market Under New Regulatory Environment June 20 14:00-18:00 Regulation Forum（Plenary Session） Zhongshan Ball Room (6 floor) 18:00-20:00 Reception Zijin Ball Room 1+2 (7 floor) 20:00-21:30 Sharing Experience of Attending PDA Annual Meeting 2013 Zijin Ball Room 3 8:30-18:05 Quality Management Forum Zhongshan Ball Room 1 8:30-17:30 Production Control Forum Zhongshan Ball Room 2 8:30-17:30 Logistics Management Forum Zhongshan Ball Room 3 19:00-21:00 Technical Q&A Zijin Ball Room 1 June 21 8:30-12:00 Parenteral Drug Product Standard and R&D Direction Forum（Plenary Session） Zhongshan Ball Room Concurrent Events: PDA Technical Trainings Event Time Venue Lecturers Note PDA Technical Training (TR No.1： Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control) June 21 9:00-17:30 Nanjing Celebrity City Hotel Mr. Kevin Trupp, Sterilization Technology Expert; Mr. Robert L. Dana, Senior Vice President, Education, PDA Separate Registration is needed PDA (TR June 22 9:00-17:30 Nanjing Celebrity City Hotel Mr. Kevin Trupp, Sterilization Technology Expert; Mr. Robert L. Dana, Senior Vice President, Education, PDA Separate Registration is needed PDA Technical Training (TR No.1： Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control) June 24 9:00-17:30 No. 3, Lane 128, Lin Hong Road, Chang Ning District, Shanghai Mr. Kevin Trupp, Sterilization Technology Expert; Mr. Robert L. Dana, Senior Vice President, Education, PDA Separate Registration is needed PDA June 25 9:00-17:30 No. 3, Lane 128, Lin Hong Road, Chang Ning District, Shanghai Mr. Kevin Trupp, Sterilization Technology Expert; Mr. Robert L. Dana, Senior Vice President, Education, PDA Separate Registration is needed Technical Training No.61：Steam In Place ) Technical Training No.61：Steam In Place ) (TR Forums June 19 (Wednesday) l Regulation Forum（Plenary Session） Time Duration Topic Zhongshan Ball Room Speechmaker 14:00-14:10 10 mins Opening Address by Chairman of PDI 2013 Mr. Zhang Wenzhou, Former Deputy Director of SFDA 14:10-15:20 70 mins Updates about Sterile Drug Inspection Under New Version GMP Official from Center, CFDA 15:20-15:50 30 mins Tea break 15:50-16:50 60 mins International Development Trend of Parenteral Drugs Mr. Robert L. Dana, Senior Vice President, Education, Parenteral Drug Association (PDA) 16:50-17:40 50 mins Latest Development of Domestic Pharmaceutical Packaging Ms. Cai Hong, Vice Chairman and Secretary General, China Drug Certification Pharmaceutical Packaging Association 18:00-20:00 l 120 mins Reception (Zijin Ball Room 1+2) Sharing Experience of Attending PDA Annual Meeting 2013 Zijin Ball Room 3 Time Duration Topic Speechmaker 20:00-21:30 90 mins Sharing Experience of Attending PDA Annual Meeting 2013 Representatives from the following companies: Parenteral Drug Association China Pharmaceutical Association of Plant Engineering Nanjing Chia-tai Tianqing Pharmaceutical Co., Ltd.; Shandong Shinva Medical Instrument Co., Ltd. JPT(Beijing) Consulting Co., Ltd. June 20(Thursday) l Quality Management Forum Zhongshan Ball Room 1 Time Duration Topic Speechmaker 08:30-9:30 60 mins Introducing the Technical Guidelines of Chemical Parenteral Drug and Glass Container Compatibility Research Mr. Sun Huimin, Director, the Institute for Medicinal Complementary Material and Packaging Material, National Institutes for Food and Drug Control 9:30-10:30 60 mins Pharmaceutical Glass Supplier Selection Mr. Deng Haigen, Former Quality Manager of Sino-Swed Pharmaceutical Crop. Ltd. 10:30-10:45 15 mins Tea break 10:45-12:00 75 mins Solution to Visible Foreign Matters Created During Sterilization of bottles for Sterile Drug With Sterilization and Drying Machine 12:00-13:00 60 mins Lunch 13:00-14:00 60 mins Qualification and Validation Aspects with BFS machines Mr. Stefan Kiesel, Holopack Germany 14:00-15:00 60 mins Applying Quality Management System in a Compliant Way in Mr. Michael Hsu, General Manager, CEFOC-Soltoris 15:00-15:15 15 mins Tea break 15:15-16:15 60 mins Influencing Factors on Liquid Product Sterilization 16:15-17:05 50 mins Process Validation of Sterilizing Filtration Mr. Zeng Fanyun, CEO, Senior Engineer, Truking Technology Limited Mr. Thomas Steger, SBM Schoeller-Bleckmann Medizintechnik Ges.m.b.H. （a Bosch branch) Mr. Taketomi Hidetoshi, Cobetter Validation Center, Hangzhou Cobetter Filtration Equipment Co., Ltd. 17:05-18:05 l 60 mins Promoting Upgrading of Pharmaceutical Industry with Scientific Regulation Production Control Forum Ms. Zhang Hua, Director of GMP Department, Center for Certification & Evaluation, Shanghai FDA Zhongshan Ball Room 2 Time Duration Topic Speechmaker 8:30-9:30 60 mins EM Program Per PDA TR-13 For GMP Compliance Mr. Michael Lee, VP-Production, DesigneRx Pharmaceuticals, Inc. 9:30-10:30 60 mins Components Processing and Compatibility Testing in Line with Global Trends Ms. Kokli Kwang , Regional Technical Support Manager, West Pharmaceutical Services, Inc. 10:30-10:45 15 mins Tea break 10:45-12:00 75 mins Latest Development of BFS Technology 12:00-13:00 15 mins Lunch 13:00-14:00 60 mins Study of Polymer Material Extractables and Leachables During Pharmaceutical Manufacturing Mr. Shen Liang, Director of Laboratory of Leachables, Merck Millipore China 14:00-14:30 30 mins Vial Filling Technology and Risk Control Mr. Luo Guoqiang, Board Director, Senior Engineer, Hunan FE Pharmaceutical Machinery Co., Ltd. 14:30-15:00 30 mins Innovative Technology and Equipment for Soft Bag Packaging of infusion Mr. Zou Zusong, Chief Engineer, Senior Engineer, Hunan FE Pharmaceutical Machinery Co., Ltd. 15:00-15:15 15 mins Tea break 15:15-16:30 75 mins Case Study for Implementing Formulation Automation system For a Filling Line Mr. Lu Di, R&D Pilot Manager, Beijing Tide Pharmaceutical Co., Ltd. Mr. Matt Safi, Managing Director, PharmaBio Solutions Ltd.; 16:30-17:30 60 mins DPTE®-XS Sterile Transfer Technology Applications in the Pharmaceutical Industry Mr. Kevin Qian, Sales Manager/ Life Science ,Getinge Infection Control l Logistics Management Forum Mr. M.-Kilian Meier, Area Sales Manager, Rommelag AG Zhongshan Ball Room 3 Time Duration Topic Speechmaker 8:30-9:30 60 mins Methods of Qualification and Validation Ms. Xu Minfeng, Deputy Director, Shanghai Food and Drug Packaging Material Control Center 9:30-10:30 60 mins Parenteral Drug Cold-Chain Logistics Operation Ms. Zhu Hong, Director, Quality Assurance, Cardinal Health China 10:30-10:45 15 mins Tea Break 10:45-12:00 75 mins Study of PDA Technical Report 58：Risk Mr. Xu Hefeng, Senior Document Management for Temperature-Controlled Distribution Manager, Northeast Pharmaceutical Group Import and Export Company 12:00-13:00 60 mins Lunch 13:00-15:00 120 mins Study of New Version GSP and Answering Relevant Questions 15:00-15:15 15 mins Tea break 15:15-16:15 60 mins Study of New Version GSP and Answering Relevant Questions Prof. Wen Xumin, Guest Professor, Institute of Executive Development, State Food and Drug Administration; One of drafters of new version GSP 16:15-17:30 75 mins Continuous Temperature and Humidity Measurement System for Drug Storage Environment Mr. Xu Guangxin, CEN China manager, Controlled Environment, Vaisala China Ltd. l Technical Q&A Prof. Wen Xumin, Guest Professor, Institute of Executive Development, State Food and Drug Administration; One of drafters of new version GSP Zijin Ball Room 1 Time Duration Questions Answering Experts 19:00-21:00 120 mins To be raised by attendees about problems encountered during pharmaceutical manufacturing Mr. Zhong Guangde, Ms. Zhang Hua, Mr. Deng Haigen, Mr. Sun Huimin, Ms. Xu Minfeng, Mr. Dun Xin, Mr. Zeng Yunfan, Mr. Kevin Trupp , Mr. Kevin Trupp etc. June 21 (Friday) l Parenteral Drug Product Standard and R&D Direction Forum（Plenary Session） Zhongshan Ball Room Time Duration Topic Speechmaker 8:30-10:00 90mins Future Development Trend of Standard for Domestic Infusion Products Mr. Hu Changqin, Chief Expert of Chemicals Verification, Research Associate, Director of Department of Antibiotics and Director of Department of Microbiological Detection, National Institutes for Food and Drug Control 10:00-10:15 15mins Tea break 10:15-11:00 45mins Requirements and Expectations on Future Parenteral Drugs from Domestic Clinical Organizations Prof. Mei Dan, Director of Pharmacy, Peking Union Medical College Hospital 11:00-12:00 60mins Medicinal products for plasma substitution – experiences, peculiarities, market trends Prof. Dr. Reinhard Weidhase, Head of Innovation Center, Serumwerk Bernburg AG List of Exhibitors Hunan FE Pharmaceutical Machinery Co., Ltd. Rommelag ag Merck Millipore The Fourth Construction Co., Ltd. of China Electronics System Engineering West Pharmaceutical Services Getinge Group SBM Schoeller Bleckmann Medizintechnik Ges.m.b.H Hangzhou Cobetter Filtration Equipment Co., Ltd. Truking Technology Limited Shinva Medical Instrument Co., Ltd. Vaisala China Ltd. Stevanato Group Sartorius Stedim Nanjing Otsuka Techbond Techno Co., Ltd. Winatech Process Engineering(Shanghai)Co., Ltd. Gerresheimer Shuangfeng King Lai Hygienic Materials Co., Ltd. Shanghai Toffl on Science & Technology Co., Ltd. JPT(Beijing)Scientifi c Co., Ltd. List of attending pharmaceutical companies 山东齐都药业有限公司 上海景峰制药股份有限公司 上海创诺有限公司 华北制药股份有限公司制剂分厂 宜昌三峡制药有限公司 安徽丰原药业股份有限公司 广州百特医疗用品有限公司 沈阳三生制药有限责任公司 哈尔滨誉衡药业股份有限公司 石药银湖制药有限责任公司 辉瑞制药（无锡）有限公司 广东怡翔制药有限公司 礼来制药苏州有限公司 华润双鹤药业股份有限公司 阿斯利康制药有限公司 无锡华瑞制药有限公司 大连美罗大药厂 北京北陆药业股份有限公司 石药集团中诺药业（石家庄）有限公司 泰邦生物集团 四川太平洋药业有限责任公司（原四川沱牌药业有限责任公司） 四川百利药业有限责任公司 神威药业集团有限公司 北京四环生物制药有限公司 石药集团欧意药业有限公司 中国生物技术股份有限公司 江苏亚邦药业集团 常州四药制药有限公司 丽珠集团利民制药厂 青岛首和金海制药有限公司 齐鲁天和惠世制药有限公司 西安市户县古城路京西双鹤药业有限公司 中国远大医药集团管理总部 四川科伦药业股份有限公司 重庆医药设计院 浙江海正药业股份有限公司 扬子江药业集团 贝朗北京办事处 江苏先声药业 湖南科伦制药有限公司 回音必集团（江西）东亚制药有限公司 苏州卫材制药 贝朗医疗（苏州）有限公司 山东博士伦福瑞达只要有限公司 上海和黄药业有限公司 南京正大天晴制药有限公司 浙江巨能乐斯药业有限公司 石家庄四药有限公司 成都青山利康药业有限公司 辰欣药业股份有限公司 青岛首和金海制药有限公司 四川百利药业集团 江苏苏中药业 天津华津制药厂 四川美大康佳乐药业有限公司 上海景峰制药股份有限公司 上海创诺有限公司 江苏恒瑞医药股份有限公司 中国大冢制药公司 杨子江药业集团 通化东宝 浙江巨能乐斯药业有限公司 河南辅仁药业有限公司 河北天成药业有限公司 重庆市莱美药业股份有限公司 南京恒生制药有限公司 常州四药制药有限公司 张家港市华昌药业有限公 山东方明药业集团股份有限公司 Pictures from PDI 2013
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